House of Commons
|Session 2006 - 07|
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Public Bill Committee Debates
Draft Human Fertilisation and Embryology (Quality and Safety) Regulations 2007
The Committee consisted of the following Members:
Emily Commander, Committee Clerk
attended the Committee
First Delegated Legislation Committee
Monday 21 May 2007
[Mr. Christopher Chope in the Chair]
Draft Human Fertilisation and Embryology (Quality and Safety) Regulations 2007
That the Committee has considered the draft Human Fertilisation and Embryology (Quality and Safety) Regulations 2007.
The Chairman: With this it will be convenient to consider the draft Human Tissue (Quality and Safety for Human Application) Regulations 2007.
Ms Winterton: It is a pleasure to serve under your chairmanship, Mr. Chope. The regulations provide an important opportunity to introduce a harmonised regulatory framework in the United Kingdom to ensure the quality and safety of tissues and cells intended for transplantation and other human applications. They will contribute to the introduction of safety standards across the European Union, facilitating safer and easier exchange of tissues and cells and securing public health protection for the tens of thousands of people receiving human tissue and cell transplants in the UK every year.
I shall outline the rationale behind the regulations and their expected benefits, main provisions and impact on business. Human tissue and cells from both living and deceased owners are transplanted in an increasing range and number of procedures. One estimate undertaken a few years ago concluded that some 10,000 patients a year benefit from NHS treatments involving human tissue transplantation. That is now thought to be a considerable underestimate of the current use of tissues and cells. The British Association for Tissue Banking has estimated that bone alone is used in 7,500 operations a year. In 2005-06, a total of 3,819 corneas were donated and 2,622 grafts were carried out. Some 2,000 bone marrow transplants, 38,000 in vitro fertilisation cycles and 7,000 donor insemination procedures are performed annually, all of which will fall within the regulations scope.
Systems are already in place in the UK to improve the safety and quality of tissue and cell transplantation. For example, in April 2001, the UK health departments launched a voluntary accreditation scheme for all tissue banks storing and processing human tissue for therapeutic use in the NHS. Under the scheme, the Medicines and Healthcare products Regulatory Agency inspected applicant tissue banks against the voluntary UK code of practice for tissue banks, which requires tissue banks to have appropriate facilities and to undertake staff training, and establishes high standards for donor screening, process control and record keeping. Similar standards are reflected in the regulations.
For more than 15 years, the Human Fertilisation and Embryology Authority has regulated the fertility sector under the Human Fertilisation and Embryology Act 1990. The HFEA is the UKs independent regulator and oversees safe and appropriate practice in fertility treatment, tissue storage and embryo research. It licenses and monitors centres carrying out IVF, donor insemination, storage and human embryo research and provides a range of detailed information and guidance for patients, professionals and the Government.
The Human Tissue Authority was established to regulate the removal, storage, use and disposal of human bodies, organs and tissue for a number of scheduled purposes, such as transplantation, as set out in the Human Tissue Act 2004. The Act covers England, Wales and Northern Ireland; Scotland has separate legislation. Since 2006, the HTA has licensed those establishments storing human tissue and cells for human application.
The regulations main benefit is that they will require all establishments dealing with tissues and cells for human applications to be regulated, ensuring that they meet high standards of quality and safety. That will maximise the benefits for patients and minimise the risks arising from infected, contaminated or poor quality tissues and cells. It is proposed to require our two competent authorities, the HTA and the HFEA, to regulate establishments carrying out procurement, processing, storage, testing and distribution of human tissues and cells intended for human applications such as transplantation.
In many respects, the provisions in the regulations will build on existing legislation and guidance. However, in a small number of areas the regulations will require the introduction of new provisions. For example, all human tissues and cells intended for transplantation in the EU will be traceable and will have to meet the same high standards. Currently, apart from in the assisted reproductive sector, there are no controls on the import or export of human tissues or cells. NHS or independent-sector clinicians can import tissues and cells from anywhere, controlled only by their own ethical duty to patients. The regulations will regulate imports and exports of tissues and cells imported from outside the EU, and will ensure that such tissues, together with those supplied from within the EU, will be both of a high standard and traceable.
UK infertility clinics are already regulated by the HFEA. However, few if any other member states had so effective a system of regulation; in fact, some had none at all. UK infertility clinics are licensed and regularly inspected by the HFEA to ensure that they operate appropriate practices that safeguard patient safety. In several areas, the HFEA has already implemented measures similar to, or that serve the same purpose as, the regulations. An example is the need for a system to report adverse events or reactions and to disseminate lessons to other establishments. There is a similar need for a person responsible at each licensed centre.
The HFEA and the bodies that represent infertility clinics have worked together during negotiation of the directive to agree appropriate practice standards. They have fed into a new edition of the HFEAs code of practice, which will be laid before Parliament shortly.
Since 2006, tissue and cell establishments that store human tissue and cells for human application have been required to be licensed by the HTA under the 2004 Act. Some 150 establishments and 118 satellites have been licensed. In addition, to enable establishments to prepare for implementation of the regulations, the HTA have made it a condition of the licence that establishments meet the requirements of the first two directives by April 2007 and work towards meeting the requirements of the third directive, as reflected in the regulations.
The regulations set out the requirement for a uniquely identifiable coding and labelling system for human tissues and cells that will underpin both the traceability and quality control of tissues and cells. An EU-wide coding system is being developed to ensure that tissues, donors, tissue bank of origin, processors and storage requirements can be instantly identified, no matter where in the EU they originate from or are used. That will eliminate confusion due to linguistic differences and enable rapid recognition of tissues sent in error, thereby preventing the use of suboptimal or unsuitable materials in human transplantation. This work is being taken forward by the EU Commission together with representatives of each member state, including the UK.
The regulations also require the introduction of a monitoring system for adverse incidents and reactions to transplanted tissues and cells, and the establishment of a system to monitor serious adverse events and reactions. Such a scheme is in place for blood and blood products and for the fertility sector through the HFEA. The HTA has developed an online system for notification of serious adverse events and reactions, and it is now operational. The establishment of a UK-wide system will complement developments such as the National Patient Safety Agencys national adverse incident reporting system, and increase public confidence in transplantation.
Gametes and embryos are within the scope of the directive and are therefore included in the regulations. The regulations also extend the remit of the HFEA to cover a range of treatments using a couples own sperm. However, feedback to date from UK-licensed clinics and professional bodies has broadly welcomed the regulations as a means further to raise and maintain standards and best practice.
The final costs of implementing the regulations are set out in the regulatory impact assessment. In summary, we estimate that set-up costs could be in the region of £16 million to £18 million, with annual recurring costs of approximately £4 million to £11 million. They are divided between administrative and policy costs.
Dr. Andrew Murrison (Westbury) (Con): Will the Minister say why the recurring costs are between £4 million and £11 million? That is an extraordinarily wide margin. Why can the Minister not be more specific?
Ms Winterton: It is quite difficult to give a definitive cost because some establishments are up to a high standard and some are not. While recurring costs might be in the margin between say, £3 million and £12 million, the NHS contribution will be up to a maximum of approximately
Giving a definitive cost has also been difficult because we have had to look at other health matters such as blood products to see what changes would have to take place to bring establishments up to standard. Certainly, costs fall within a wide range. We have tried to be as flexible as possible in making an estimate, but it has not been easy. When we look at the costs spread across the NHS, we should recognise that the amount is not an undue burden on individual PCTs. Also, the measure will raise quality and standards across the whole sector.
Dr. Murrison: I accept that spread across the NHS, the burden per PCT will be relatively small. The Minister has not, however, explained to my satisfaction why there is such a wide margin of error. What variables will impact on the question of whether the costs will be toward the lower or upper end of the margin?
Ms Winterton: As I said, the Government have tried to provide as wide-ranging a measure as possible because it has been difficult to look at every clinic or tissue bank individually and to say exactly what systems are in place. An air conditioning system, for example, might cost money to maintain over a period. That means that it is difficult to say that the maximum costs will be X, Y or Z. In the worst-case scenario, the costs to the NHS will be something like £7.5 million spread between 150 PCTs, which is approximately £50,000 per PCT. The regulations have been drawn up by involving not only the NHS, but the independent sector, so people are well aware that the changes are on the way and are prepared for them.
We have had to look at health care areas in which similar systems are in place, to see what changes might be necessary. It will of course be for individual clinics and banks to satisfy us that they have the proper standards in place to guarantee quality.
Norman Lamb (North Norfolk) (LD): The regulatory impact assessment deals with this question. It says that a sample of only two units with widely divergent costs was used. Does the use of such a sample make the assessment meaningless because of the divergence between the two units? Would a sensible RIAone that has some meaninghave to have more information about the extent to which units will have to raise their standards to meet the requirements of the regulations?
Ms Winterton: In drawing up the regulations, we tried to work very closely with all the organisations concerned, whether from the NHS or the private sector. Everybody agreed that these are the standards that they wished to see implemented in the UK, so this cannot have come as a surprise. We could have gone round all 150 centres and 118 satellites, but given that there is likely to be a range from the current standard to the highest standard, we had to make an estimate from that.
It has not been easy to go around every single establishment. However, because we have consulted widely, the regulations will not come as a surprise. Individual PCTs and independent sector organisations will be well prepared. It is also important to recognise that there will be administrative costs. To a certain extent, those will depend on what administrative support individual organisations might have in place and on the additional testing requirements that there may be. We also know that many establishments have already introduced the measures necessary to comply with the regulations, so we do not expect a significant impact on business in either the public or the private sector.
I hope that we can all agree that when we talk about issues such as fertility clinics and tissue banks, it is important that people have confidence in the health services. People have a right to expect high levels of protection in terms of safety and quality. The regulations will impose very clear standards of quality and safety for the donation, procurement, testing, processing, storage and distribution of all human tissue and cells used for any human application, including fertility procedures, across the European Union.
Mr. David Burrowes (Enfield, Southgate) (Con): On the processing and timing of the regulations, why was it appropriate to follow through with the regulatory framework nowI appreciate that there is the background to do sorather than taking advantage of the timing of the draft joint Bill, which is beginning to make its way through Parliament, and using the primary legislative route to consider the measure in detail?
Ms Winterton: We are implementing a directive, and this instrument is the procedure that is used. We could have waited, but what is important is that we take advantage of the fact that we are currently able to implement a lot of the changes already set out in the regulations. We know that we have high quality and safety standards in the UK. There are European Union deadlines to meet and it would be unwise to wait until possible legislation when in fact, to meet the deadline we need to get on and to do this now through what is a generally accepted procedure in both Houses.
Dr. Harris: My question relates to the point made by the hon. Member for Enfield, Southgate. Had the timetable for the draft Bill, the Bill, the new Bill and then the draft Bill not slippedbecause the consultation had slippedwould the Government have used primary legislation as a way of implementing the regulations? Was the intention always to use section 2 of the European Communities Act 1972?
Ms Winterton: It was always our intention to do it like that, it being the quickest and most effective way to implement what are fairly uncontentious regulations.
I am grateful to the Minister for her extensive description of the regulations. Again we find ourselves using parliamentary time to rubber-stamp directives over which we have little control. However, that may not detract from their quality. The right hon. Lady was bullish in extolling the virtues of this set of regulations which, as she says, deals with quality. I am pleased that she underscored the quality that we enjoy in this country in respect of the handling of human tissues. She and I debated such matters at some length in the not too distant past when we discussed the Human Tissue Bill.
The guidance notes say that most requirements in the directive are not new to licensed institutions or that they are established good practice. That gives rise to the question as to why we need them at all in such an extensive form. Both sets of guidance notes state:
Regulations do address other areas not currently covered by the 1990 Act
and the Human Tissue Act 2004. I listened carefully to the Minister and the only issue that I could pick out that was not already covered by the Human Tissue Act, in particular, was the need for traceability. Will she explain what other aspects surrounding the handling of the material in the United Kingdom need to be addressed by the regulations and what quality they will add?
We could be worried about other countries. If so, I invite the Minister to say which particular countries she thinks have a particular problem. What pressure will be brought to bear on those countries to ensure that they come up to speed and emulate the quality to which she referred? How long will it be before the directives are implemented fully throughout the European economic area? If we are worried about standards abroad, what is the status of non-EU countries with which we exchange material? What proportion of material exchanged is UK, European Union and non-EU sourced? Clearly, that is important.
The Minister spent some time describing how many procedures are carried out. An extensive list of procedures involve human tissue, but she did not explain what proportion of those procedures were performed using material from various sorts. If tissues, gametes and embryos must be marked with an EU-wide coding system, what are the implications for non-coded, non-EU material?
On 14 May 2007, Lord Hunt said that the
imports and exports of tissues and cells imported from outside the EU[Official Report, House of Lords, 14 May 2007; Vol. 693, c. 95.]
will ensure high standards and traceability. Paragraph 15 of the Human Tissue (Quality and Safety for Human Application) Regulations 2007 does indeed allow for licence holders to be obliged to ensure that the imports of tissues and cells from non-EEA states meet the same standards of quality and traceability as those for EEA countries. However, I could not find a similar requirement in the Human Fertilisation and Embryology (Quality and Safety) Regulations 2007. Presumably neither of them will have to comply with the EU-wide coding system, which in any case is still under development.
I hope that the Minister can explain how non-EEA material will be managed under the Human Fertilisation and Embryology (Quality and Safety) Regulations or point to some other regulations that will guarantee the traceability and quality of gametes and embryos. Without such a guarantee, the regulations could have a paradoxical effect, because there is the potential for less desirable non-EEA material to be favoured by clinics eager to exploit a loophole. Can she say how the Human Tissue Authority will ensure that licensees apply the same standards to human tissue from non-EEA states and from EEA countries? The trafficking of human tissue is a scandal and I am especially keen to learn how these regulations will reduce the likelihood of EU countries, particularly the UK, becoming involved.
We learn that traceability data must be kept for 30 years. How has the Minister chanced upon 30 years? When questioned by Earl Howe in the other place on 14 May, Lord Hunt did not seem to know why 30 years had been chosen. If we are worried about the transfer of prions, for example, who can say whether 30 years is long enough? It will be interesting to know what extra cost would be involved if that 30 years were extended, say, to 40 or 50 years. The regulations create a single regulatory framework for reproductive and non-reproductive tissue banking, which paves the way for the merger of the HFEA and the Human Tissue Authority. I reiterate Earl Howes observation to the effect that we reserve judgment on the desirability of that merger.
The Minister has said that compliance will cost between £16 million and £18 million, with recurring costs of between £4 million and £11 million. I am still not clear why we have such a wide margin for recurring costs. I accept her assertion that for the NHS that boils down to a mere £50,000 per primary care trust. I do not know about the Ministers PCT, but mine would rather resent the implication that £50,000 is a mere bagatelle. Does she accept that, given the disproportionate cost of regulation on small enterprise and her Departments admission that practice is already good in the UK, the 80 per cent. of infertility clinics that are classified as small firms will be disproportionately affected by that?
According to Lord Hunt, 11 organisations have already decided not to register under the regulations. What reason can the Minister come up with for that? Is it cost? Have they shut up shop completely or have they moved away from the European Union in order to avoid them?
Norman Lamb: It is a pleasure to serve under your chairmanship, Mr. Chope. I will keep my remarks brief. I am sure that the Committee will be pleased to hear that I want to ensure that my hon. Friend the Member for Oxford, West and Abingdon has an opportunity to contribute to the debate as well. However, I want to make it clear at the start that the measures are uncontroversial and we support them. I am grateful to the Minister for having set out their extent with such clarity.
It makes sense for there to be EU-wide standards in this area, but the hon. Member for Westbury started
Dr. Murrison: I tend to agree with the hon. Gentleman so long as the majority of transfer happens between EU member states rather than within the UK or between the UK and non-EEA countries.
Norman Lamb I am grateful for that intervention. The hon. Gentleman raised some reasonable concerns about activities beyond the EU. I wanted to ask questions on those points, which none the less do not seem to diminish the case for EU-wide standards. I know that my hon. Friend the Member for Oxford, West and Abingdon may want to raise some questions about the extent of the application of the regulations; I shall leave that to him.
In commenting on the position throughout Europe, the Minister suggested that the UK had been well ahead of the rest of Europe in regulating standards in this area. I absolutely accept that. The Departments helpful guide makes the point that the directive was to be implemented throughout the rest of the EU by 7 April last year, so it has been in force for more than a year. Will the Minister provide an update on the position throughout the EU? Has the directive been implemented in accordance with the requirement, or does she anticipate infraction proceedings against a number of countries? I heard a Labour Member refer to Greece in the context of countries with which there may be problems over standards. Will she confirm whether there are concerns about any particular EU countries, particularly Greece?
The hon. Member for Westbury raised concerns about matters beyond the EU. Are there concerns about standards not being sufficiently high in particular jurisdictions from where a significant proportion of supply comes? The guidance notes refer to the fact that the regulations will cover the emerging internet market, which is notoriously difficult to regulate. Does the Minister have any observations on whether she regards that as an area of concern that needs attention to ensure sufficiently high standards, particularly given that the sourcing may well be beyond the EU?
The Minister responded to interventions on the wide range of ongoing costs of applying the regulations. I was concerned at the implication of the comment of the hon. Member for Westbury that there may be a disproportionate impact on small firms. It is self-evident that the standards have to apply to all clinics and units, irrespective of size. The point is to ensure that the regulations do not go beyond what is necessary to ensure high standards. Once we have established what is necessary, however, that has to apply across the board, irrespective of the size of the organisation, even if that has a disproportionate effect on smaller companies.
Dr. Murrison: Of course, standards have to apply equally to firms of all size. The point that I was trying to make was that, in the regulatory impact assessment,
Norman Lamb: I certainly was not trying to twist the hon. Gentlemans meaning. Once one establishes the necessary standards, they have to apply across the board, even if they have a disproportionate effect on smaller firms. The regulatory impact assessment assesses the total benefit that we can expect from the regulations. It gives a figure of £9 million, but it makes it clear that that is, in effect, a stab in the dark. Is the Minister confident that it is a reasonable estimate of the potential benefits, or could she give us more guidance? Those are the questions that I wanted to put to the Minister. Overall we accept the purpose of the regulations and are happy to support them.
Dr. Harris: I just have a couple of supplementary questions to those put by my hon. Friend on the internet supply of sperm services and related matters. I am not sure whether it is squeamishness on the part of other members of the Committee that this issue has not been raised so far. As the Minister well knows, the greatest interest has been in the extension of regulation to the use of fresh gametes for commercial purposes such as by the ManNotIncluded website and similar provisions. I also want to raise a question about the impact of the welfare of the child clause and its inter-relation with these regulations and with the draft Bill on human tissue and embryos.
In relation to fresh gamete services, my understanding is that the Human Fertilisation and Embryology Act 1990 applies only to gamete services that involve the storage of sperm as well as the creation and storage of embryos. The idea behind unregulated services such as ManNotIncluded is that women can get fresh gametes for self-insemination without there being a storage phase. The Governments view was that the directive requires those services now to be regulated and I do not dispute that. My question to the Minister is whether the Government have an understanding of where the line will be drawn.
A company that advertises a commercial service of fresh gamete supply for the purposes of insemination or any other purpose would be covered, but would a non-commercial operator also be covered? My reading of the regulations is that it would because gametes are being procured. If so, what is the status in law of the quite well known very informal arrangements between individuals in this country who use a friends gametes for self-insemination in order to overcome fertility issues? [Interruption.] I notice that there is giggling on the Front Benches, but it is an important issue.
Many lesbian couples use a gay mans sperm in order to avoid the humiliation of being turned down for treatment services under the 1990 Act with its discriminatory provision of having regard to the need of the child for a father. The Government, in their draft Bill, have accepted that that is discriminatory under their own Equality Act (Sexual Orientation) Regulations on the provision of goods and services. That is a commonly used scheme. If
My second question is only somewhat related. Basic treatment services are now going to be included in the provisions. I note from the very helpful document that the Minister provided, which sets out what the HFE Act will look like with these new regulations, that the welfare of the child provision, in its unamended form with the discriminatory provision about having regard to the need of the child for a father, will now even apply to basic treatment services. Section 13(5) states:
A woman shall not be provided with treatment services, other than basic partner treatment services, unless account has been taken of the welfare of any child who may be born as a result of the treatment.
In that transposition, it appears that basic partner treatment services are not subject to that provision. But paragraph 105 on page 106 of the explanatory notes to the draft Bill states:
The power under which the regulations implementing the EU Tissue Directive are to be made (section 2(2) of the European Communities Act 1972) is not regarded as giving power to apply the welfare of the child provisions in section 13(5) of the 1990 Act to the provision of basic partner treatment services as defined in the 1990 Act as amended by the regulations. Clause 20(2)(a)
of the draft Bill; it is actually clause 21(2)(a)
amends section 13(5) so that it does apply to the provision of basic partner treatment services.
Could the Minister explain what is meant by basic partner treatment services?
I understand that if the draft Bill is passed, the need-for-a-father provisions will be got rid of, but if the basic partner treatment services are also to be subject to a welfare-of-the-child test, it is important that the Minister explains what they are, and why a series of further couples will be subject to a discriminatory provision where they have to show their suitability as parents in a way that non-infertile people do not need to do.
The Minister will be aware that there is controversy within the welfare-of-the-child discussions even without the need-for-a-father provisions. It would be helpful to know what she means by basic treatment services in that regard. If she can deal with those two questions, I will be happy to leave it there.
Ms Winterton: I shall start by addressing some of the issues around other member states and how long it may take them to comply with the directive. We do not have data on other member states. As I said, in this country, we still have an advantage because we have very high standards and thus have a head start.
The European Commission is carefully monitoring compliance and it is already clear that it is prepared to begin infraction proceedings if any member state fails to implement the directive or to delay implementation unduly. We have made it clear that if we have any worries about other member states not complying, about the quality of tissue and so on coming into the UK, or about clinics using sub-standard material or material that has not been kept to the high quality that
Norman Lamb: Is the Minister aware of any particular areas of concern at present, either within the EU or beyond?
Ms Winterton: We are not aware of any concerns at the moment, but the regulatory authorities are keeping an eye on the matter. In this country, we have a lot of experience in knowing how to ensure that standards and quality are high because we have already set up regulatory bodies. The labelling and coding that will follow from the regulations will be an important part of ensuring that we can monitor the quality of imports.
Mr. Kevan Jones (North Durham) (Lab): I give the Minister an example, although it does not relate to embryology tissue. My constituent Christopher Rochester died five years ago on the island of Rhodes. One of his kidneys was removed for unexplained reasons, and some two years later it was returned to the UK, where it was discovered that the kidney was not his. The Greek authorities deny that, and there is a protracted legal dispute about it. My experience of dealing with the Greek authorities on the transfer of human tissue, in this case a kidney, is very poor.
Ms Winterton: My hon. Friend brings me neatly to the issue of traceability. Hon. Members asked about the figure of 30 years and I can reassure the Committee that no specific factor determined why the 30-year figure was chosen. It was arrived at by negotiation between the member states, as it is likely that patients could develop medical conditions that might be related to the use of transplanted tissues and cells many years after the transplant took place. Thirty years was considered to be an appropriate amount of time to retain such records to assist diagnosis of such conditions and, if necessary, to ensure that the tissue donors can be traced, should there be any medical implications for them.
My hon. Friend is right to draw attention to the importance of considering such issues and why it is important to have a European-wide approach on safety issues.
Mr. Jones: I totally agree with a European-wide regulation for tissue but the problem is that that does not mean anything in practice in Greece and certainly not on the island of Rhodes. The Greek authorities are still, in this case, disputing the facts, even though the kidney that I mentioned was DNA-tested in this country and found not to be the kidney of my constituent; obviously it is the kidney of some poor Greek citizen. They are refusing to accept that kidney back or explain to the family what has happened to the original kidney. Although I agree with my hon. Friend about European-wide jurisdiction, I am not sure that it addresses what happens in practice.
Ms Winterton: I am sure that all members of the Committee would agree that we are trying to improve the current situation so that it is much more reliable.
I shall briefly answer a number of the questions that were asked. First, in terms of the points made by the hon. Member for Oxford, West and Abingdon, about the welfare of the child, these directives cover safety and quality and do not venture any further. He was referring to other legislation, which is not covered by these regulations. If I can illuminate him by writing to him about the cross-over with other legislation, I shall be more than happy to do so. However, I wish to make clear that these regulations simply talk about the safety and quality of storage, and knowing where the tissues and so on come from.
Dr. Harris: I accept that I was not perhaps as clear as I should have been. These regulations insert basic partner treatment services into section 13 of the 1990 Act, with the intention, declared later on, that those will then be covered by the welfare-of-the-child provision, albeit that the regulations do not allow the Government to carry out their declared intention to ensure that the welfare-of-the-child test is applied to that. Those basic partner treatment services include non-gamete, non-embryo services, which do not involve sperm or embryos at all. Patients who may need hormonal treatment will be subject to that discriminatory test about whether they will be good parents in a way that most other parents are not. What is the justification for inserting that in that section? The Minister did not have to issue the regulations, so why is she doing so?
Ms Winterton: As I have said, the regulations follow on quite long periods of negotiation and consultation with all interested parties. In a sense, the different provisions have been inserted, not with the purpose of creating a hook to other legislation, but because of the purposes of the directive itselfto ensure high quality and safety.
I move now to the new areas about which the hon. Gentleman asked. Obviously, there is not only the traceability, but the reporting of serious adverse events and the sperm testing processors. There is artificial insemination using the partners own gametes, and there is also internet sperm delivery.
I would like to expand a little on the internet sperm delivery proposals. Currently, internet sperm delivery is not subject to regulation, so patients must take the suppliers word on testing and so on. However, internet sperm providers will now be subject to the same regulatory requirements as clinics providing donor sperm, so that patients can now be assured that the sperm that they receive is safe. Those are some of the new procedures that will be covered.
Dr. Murrison: The Minister mentioned sperm testing procedure and I simply do not know what she has in mind; perhaps she could inform me.
Ms Winterton: It is a series of tests to ensure that the sperm is safe and that it has been properly stored and is of high quality.
With regard to non-EU countries, I can assure the Committee that clinics will need a licence to import from non-EU countries and that the licensers will require them to meet similarly high standards. Of course, the
On the subject of fertility clinics that are closing, I think that there have been about 11 closures, for various reasons; some closures are connected with the clinics still trying to get an IVF licence. Four of the 11 clinics that have closed did not give a reason for closing. However, we must be absolutely clear that what we are trying to do here is to ensure that there are high standards of quality and safety. If, to a certain extent, some clinics do not feel that they wish to meet those requirements, we must be absolutely clear that we must think of the patients, the people using these clinics. We must send a clear message that we expect high quality maintenance of supplies.
As I have said, there has been widespread consultation on these regulations over a number of years. There is general agreement that we are taking the right approach to safety. We must accept that, if some people do not wish to go along with that approach, that is absolutely up to them. However, I believe that it is our job to say what we expect in terms of delivery.
Dr. Harris: I am satisfied with the Ministers answer to one question, but I raised the issue of those people who are not using internet providers of gametes, but are just using gametes provided by a friend. It seems that the definitions in the measure go more widely than the internet; they do not mention the internet. As far as I know, they do not use the words commercial or professional, although I may be wrong about that.
Ms Winterton: These regulations will not affect those private arrangements. As I have said, what we are discussing here is, in many cases, what is provided by clinics in terms of the human tissue, safety and storage. It is not feasible to cover the other issues.
As I have said, we should generally welcome these regulations, which will provide for higher quality in the services given to patients and ensure that there is greater degree of confidence among service users and that reliable and high standards exist both across and outside the EU. I commend them to the Committee.
Question put and agreed to.
That the Committee has considered the draft Human Fertilisation and Embryology (Quality and Safety) Regulations 2007.
DRAFT HUMAN TISSUE (QUALITY AND SAFETY FOR HUMAN APPLICATION) REGULATIONS 2007
That the Committee has considered the draft Human Tissue (Quality and Safety for Human Application) Regulations 2007.[Ms Winterton.]
Committee rose at t wenty - six minutes past Five oclock.
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